MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA GLIDEWIRE ADVANTAGE; WIRE, GUIDE, CATHETER

Model Number	GA1830
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the procedure was a peripheral intervention on the anterior tibial vessel of the left leg via right groin access.A 6 french destination sheath was advanced up and over the iliac bifurcation.The 018 gwa was advanced across two heavily calcified lesions.An 018 navicross was advanced over the wire with intention of wire exchange for the viper wire.When the physician pulled back on the wire, there was much resistance.They were unable to capture the wire in the navicross.Navicross was removed leaving wire in the anterior tibial vessel.The physician carried on with the procedure and the procedure was a success.At the end, the physician was able to safely remove the wire.On removal, the wire appeared to have been stripped of the plastic jacket toward the distal end of the wire.All parts of the plastic jacket were intact.They are crimped up at the tip and nitinol internal wire exposed.The physicians' assessment was that the wire was pinned and stripped between two chunks of calcium.There was no blood loss.Additional information was received on 25jul2025: the patient was stable, and the case was a complete success.The wire was unable to track through an 018 navicross; however, it was able to be withdrawn through the sheath.Additional information was received on 28jul2025: the 6 french destination used as an auxiliary device was not a product manufactured by ashitaka.The 018 navicross was not considered a contributing factor to the user.The calcium within the vessel was reported as the assumed culprit.

• Brand Name: GLIDEWIRE ADVANTAGE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya, shizuok 418-0 015; JA 418-0015
• MDR Report Key: 23006656
• Report Number: 2243441-2025-00048
• Device Sequence Number: 21459900
• Product Code: DQX
• UDI-Device Identifier: 04987350714763
• UDI-Public: (01)04987350714763(17)260930(10)241023
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2025
• Report Date (Section F): 09/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: GA1830
• Device Catalogue Number: RA*FA18301C
• Device Lot Number: 241023Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/20/2025
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/09/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/09/2025